Pulmonary Artery Catheter in Cardiogenic Shock Trial — PACCS  

Heart Failure Clinical Trial

Official title: The Pulmonary Artery Catheter in Cardiogenic Shock Trial

Status Recruiting

Clinical Trial Summary

The primary objective of the PACCS trial is to assess if early invasive hemodynamic assessment and ongoing management with a PAC in patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS) is associated with lower in-hospital mortality risk compared to the current standard of care with no or delayed PAC assessment.

Clinical Trial Description

The PACCS trial is a multicenter, randomized, parallel group, adaptive trial that will test the hypothesis that early invasive hemodynamic assessment (within 6 hours of randomization) and ongoing management with a PAC decreases in-hospital mortality compared to clinical management with delayed (beyond 48 hours after randomization) or no PAC-guided assessment among patients with cardiogenic shock due to acutely decompensated heart failure (AHDF-CS). The trial uses an adaptive sample size re-estimation design. An interim analysis will be performed when the primary endpoint is available for 200 participants and may lead to an increase in the target sample size (minimum sample size 400, maximum sample size 800). ;

Related Conditions & MeSH terms

• Cardiogenic Shock
• Heart Failure
• Shock
• Shock, Cardiogenic

• NCT number: NCT05485376
• Study type: Interventional
• Source: Tufts Medical Center
• Contact: Karol Walec
• Phone: 617-636-4907
• Email: kwalec@tuftsmedicalcenter.org
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2022
• Completion date: September 1, 2026